The present invention relates to the sector of devices used to obtain and/or improve knowledge of the times of greatest or least xe2x80x9cfertilityxe2x80x9d in women during the monthly menstrual cycle and to identify with a good measure of probability the day when ovulation occurs, for the purposes of contributing to knowledge of the most or least appropriate periods for conception.
More particularly, the present invention relates to a device which proves useful and effective in detecting, by means of a totally natural method and without the use of either chemicals or xe2x80x9cinvasivexe2x80x9d procedures, the fertile days and the time of ovulation in women with a very high degree of approximation (such as to allow various applications both in the field of physiological events and in that of medical intervention).
The invention relates essentially to a detection system for assessing information closely related to changes of a physical type in a number of body fluids which can be collected without invasive measures, such as saliva and other fluids which will be specified here below.
In the light of the present state of our technical and scientific knowledge, it is known that, in the course of the menstrual cycle, important, essentially hormone-based physiological transformations take place in the woman for the purposes of optimising the conditions for possible conception. Since this xe2x80x9cnaturalxe2x80x9d program has a very strong functional purpose, it comes about that various biological variables related to it, despite the xe2x80x9cbiological variabilityxe2x80x9d which is always present, take on a character and values which tend to be deterministic and leave little room for chance.
These variables are numerous and different in nature, such as hormone levels, body temperatures, density and viscosity of certain fluids, i.a. As the days of the cycle leading up to the time of ovulation and then following ovulation pass, these variables change in value and thus reflect actual physical changes in a number of elements of the body.
It is also well known that the woman""s fertile period occurs only once in the course of each menstrual cycle. The ovum matures around mid-cycle, roughly 14 days after the start of the last menstruation. The fertility period, i.e. the days when the ovum can be fertilised, covers a maximum of 5-6 days (with a greater chance of fertilisation on the 2-3 central days of the period).
Identification of this short period of xe2x80x9cmaximum fertilityxe2x80x9d is not easy, unless sophisticated, expensive and sometimes also xe2x80x9cinvasivexe2x80x9d methods are used. The various traditional methods based on calculations and subjective observations are very imprecise and not always easy to use. All this often leads to practical consequences of substantial distress in couples that desire to conceive a child or who would like to implement proper family planning on the basis of wholly natural methods. In recent years, then, substantial efforts have been made in an attempt to develop reliable, easy-to-use predictive tests, based on changes in the above-mentioned biological variables which mark the various phases of the cycle in the woman.
One variable often used for this purpose is basal temperature, which, as is known, tends to rise at the time of ovulation. The use of this variable, which can easily be measured with special ad-hoc thermometers, yields information which is sometimes not particularly accurate and is often influenced by other factors.
Another variable considered is the viscosity (either subjectively assessed or measured using an instrument called a viscosimeter) of the uterine cervical mucus, which is not always easy to assess.
All these variables, moreover, require evaluation not only of the xe2x80x9cpresentxe2x80x9d value, but also of the variations compared to the last few days. Their reliability in practical use has therefore often proved fairly poor.
One very reliable variable which is less influenced by other factors is the luteinising hormone (LH) level in the female body. It can be measured precisely with sophisticated laboratory equipment and, more recently, with the introduction of special kits on the market, it can also be measured at home; these kits are quite expensive and, for reliable conclusions regarding fertility, again require comparison with results obtained on a number of consecutive days.
Lastly, we should recall that comparative tests performed by authoritative investigators have shown and confirmed that, during the menstrual cycle, the woman""s saliva (or other fluids such as cervical mucus) undergoes structural changes as a result of the oestrogen levels circulating in the body; as a result, over a period ranging from 2-3 days before ovulation (oestrogen peak) to 2-3 days after ovulation, a physical phenomenon of microscopic xe2x80x9ccrystallisationxe2x80x9d of saliva occurs, which, in turn, can be recognised and, if properly interpreted, used to understand which phase of the cycle the woman is in from the fertility point of view.
The above-mentioned observations are summarised in the following specification which also allows comparison with the information that the woman can obtain using the various xe2x80x9cnaturalxe2x80x9d methods outlined above.
In the light of the present state of our technical and scientific knowledge, it can be stated that this latter effect of crystallisation of saliva, known as the xe2x80x9cfern effectxe2x80x9d, in that the crystals present the appearance of the fronds of a fern, has been used in laboratories and in specialist medical studies in order to xe2x80x9cseexe2x80x9d the crystalline structure indicating a pre- or post-ovulation condition under the microscope, thus allowing conclusions to be drawn as to the woman""s fertility status. Small microscopes for personal use have also been produced for said purpose.
The above-mentioned approach also affords advantages particularly when used in conjunction with other natural methods, but it also presents a number of drawbacks related mainly to the need to perform calculations and take account of the results of previous days, as well as a certain amount of objective difficulty in collecting samples of saliva (which prove hard to compare) in a simple, standardised manner over time.
The object of the present invention is a device suitable for detecting changes in the xe2x80x9cstatexe2x80x9d of fluids, such as saliva, in response to a rapid increase in oestrogen levels in the body and other changes closely linked to the approach and occurrence of the physiological phenomenon of ovulation (which, as already mentioned, is a phenomenon with an intense deterministic component, that strongly influences the changes observed).
More particularly, the object of the present invention is a kit as described in the preamble of claim 1 attached hereto, characterised in the characterising clause of the same claim.
The present invention makes it possible to overcome the various limitations of the above-mentioned systems (difficulty in collecting standardised samples of saliva or other fluids; poor sensitivity related to visual observation of saliva placed on surfaces with undefined limits, such as slides, lenses or the like; the need to save the results of preceding days with the difficulty of detecting the onset of changes which are not particularly marked as compared to previous findings).
In fact, the object of the present invention consists in a kit made up of:
a device for collecting and storing samples consisting of a set of flat plate-shaped supports (hereinafter called xe2x80x9cpetalsxe2x80x9d) made of special material, as specified here below, with an entirely original design which enables the fluid samples (saliva or other fluids) to be collected in a homogenous, standardised manner by implementing a kind of automatic mechanism as will be explained later in this description. Said set of petals makes it possible to obtain: greater reliability of results due to the standardised collection of fluid in constant amounts; greater sensitivity due both to the quality of the sample and to the way the petal is constructed, with the possibility of easy comparison with the results of groups of subsequent days with immediate detection of any changes and with the further possibility of saving indefinitely the effective results (xe2x80x9cvaluesxe2x80x9d of the variables used, with the consequent possibility of comparing them over time with later cycles, checks, interpolations and extrapolations);
a petal readout device consisting in a viewer of appropriate shape, as described here below, in which the petals can be inserted for the purposes of the optical or electrical or mixed optical-electrical detection of the crystallisation of saliva or other fluids. The mixed system may substantially enhance the sensitivity of the device with only a slight increase in cost, inasmuch as the electrical component can be realised at only limited extra expense.